Historyall about redsense blood loss detection

History

Headquartered in Halmstad in the South of Sweden, Redsense Medical traces back to the year 2000, after a number of incidents with venous needle dislodgement during Hemodialysis in Halmstad County Hospital. The nurses came to the realization that these incidents were far from unique and that existing alarm systems were widely notorious for malfunctioning. The hospital technicians contacted engineer Daniel Engvall, co- founder of Redsense, looking for a solution to this problem.

Daniel started a project with the goal of developing the first monitoring system for venous needle dislodgement during hemodialysis. The project was supported by Innovation Team, a well-established design company in the medical technology sector, and together with the local company Micropol, who today is still a supplier of Redsense, a first prototype was developed.

In late 2003 the development of the first product prototype was finalized and in 2004 a patent protecting its basic technology was filed. During the development process, the team evaluated existing methods and, instead of attempting to measure activities inside the body or the dialysis equipment, designed a device which keeps an eye on the access points and monitors for the first sign of blood loss. An absorbent patch, which contains a blood sensor, is placed directly over the venous needle blood access point to absorb the blood that flows out from the patient in a situation where venous needle dislodgement occurs. The sensor inside the patch is connected to an external alarm unit to allow the sensor patch to be as small and simple as possible.

In 2006 Patrik Byhmer, board member of Innovation Team, came across the project and founded the company Redsense Medical AB was founded as a spin-off of the project, together with Daniel Envall and help from investors.

Company Milestones

2016

Governmental decision to increase hemodialysis in Czech Rep. - cooperation with B.Braun in Czech Tep. - also in Slovakia.

Villingen-Schwenningen as first German user of Redsense for home hemodialysis.

Insurance in the US covers use of Redsense in treatments - demand increases »Dialysis Clinic Inc (USA) uses Redsense for new hemo- and nocturnal dialysis plan in their over 230 clinics with around 15 000 patients.

The international Electrotechnical Commission's (IEC) committee for dialysis has clearly stated in the standard for dialysis equipment (IEC 60601-2-16) that the pressure alarm is not sufficient to detect VND - PAS63023 was released, which allows a dialysis machine to communicate with an external alarm. Nikkiso DBB-EXA machine integrates Redsense bloodloss alarm this way.

Redsense CDC patch for catheter approved for use in Europe and CE marked, and approved for sales in the USA.

2015

NxStage receives clearance for at-home nocturnal dialysis in the US, with Redsense written on the label. Launch starts in Fbruary 2015.

Listing on the Swedish Stock Market.

2014

Production start of the 2nd generation Redsense alarm.

Launch of the new generation begins in april to existing customers in the US, UK and the Nordic countries. Product launched in the Netherlands in June.

Together with a supplier, Redsense Medical receives funding from the Eurostars project (an EU project for innovations by European companies).

2013

CE marking of the 2nd generation Redsense, i.e. the product is approved for sales in Europe

Commercial availability of the 2nd generation Redsense in the US, i.e. the product is approved for sale in the USA

2012

A license and financing agreement is struck with a company in the industry (NxStage Medical Inc., which is listed on Nasdaq).

2007 - 2011

Becomes CE marked and thus approved for sale in Europe.

First order from the Royal Western Infirmary Hospital in Glasgow, Scotland.

Receives FDA 510K clearance (2007), in other words, approved for sale in the USA. Centers for Medicare & Medicaid Services confirm that the Redsense product will be covered by Medicare.

Redsense Medical AB receives ISO13485 certificate.

FDA 510K clearance for home dialysis » US Government of Veteran Affairs (VA) makes the use of Redsense for high-risk patients mandatory.

FDA510K clearance for nocturnal treatment in clinic (2010)

The Redsense Medical group is established through the foundation of the wholly-owned subsidiary Redsense Malta and Redsense Medical Inc. in the USA.